透皮贴剂的技术及质量控制进展

目的：介绍透皮贴剂的上市药品进展、剂型技术进展与质量控制要求。方法：检索并梳理归纳透皮贴剂上市情况以及贴剂类型、基质种类、皮肤吸收、促渗技术、质量控制方面的研究文献和相关技术指导原则。结果与结论：综述了透皮贴剂的剂型特点、技术进展以及系统总结了透皮贴剂的质量控制指标，建议应重点关注透皮贴剂的体外药物释放度、皮肤渗透性、黏附力、冷流和药物残留等关键质量属性。

Research Progress in Technology and Quality Control of Transdermal Patches

Objective: To introduce the development of transdermal patches in the market, the progress of dosage forms technology and the requirements of quality control. Method: The patches marketing status, the relevant research literature and the technical guidelines of patches type, matrix type, skin absorption, penetration enhancement, and quality control were searched and summarized. Results and Conclusion: The dosage forms characteristics, technological progress of transdermal patches were reviewed, and the quality control indicators of transdermal patches were summarized systematically. It was suggested that more attention should be paid on the key quality attributes of transdermal patches such as in vitro drug release, skin permeability, adhesion, cold fl ow, and drug residue.